Recall Z-0524-2019— GE Healthcare, LLC

Name: FDA recall Z-0524-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-31

Class II · Ongoing

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2018-08-31. It names 3 FDA 510(k) clearances: K033964, K030575, K990068. Product: Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.. Reason: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time..

Recalling firm: GE Healthcare, LLC
Classification: Class II
Status: Ongoing
Initiated: 2018-08-31
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

3 on FDA's record

K033964 — SOLAR 9500 INFORMATION MONITORGe Medical Systems Information Technologies·cleared 2004-01-15
K030575 — MODIFICATION TO SOLAR 9500 INFORMATION MONITORGe Medical Systems Information Technologies·cleared 2003-03-21
K990068 — SOLAR 9500 INFORMATION MONITORGeneral Electric Medical Systems Information Techn·cleared 1999-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Solar 9500 Information Monitoring System is used to monitor physiologic parameter data on adult, pediatric and neonatal patients.

Reason for recall

The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

Data sourced from openFDA. This site is unofficial and independent of the FDA.